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Last Updated: November 24, 2020

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EPIDIOLEX Drug Profile

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Which patents cover Epidiolex, and what generic alternatives are available?

Epidiolex is a drug marketed by Gw Res Ltd and is included in one NDA. There are thirteen patents protecting this drug.

This drug has seventy-two patent family members in seventeen countries.

The generic ingredient in EPIDIOLEX is cannabidiol. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cannabidiol profile page.

US ANDA Litigation and Generic Entry Outlook for Epidiolex

Epidiolex will be eligible for patent challenges on September 28, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 28, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for EPIDIOLEX
Drug Prices for EPIDIOLEX

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Generic Entry Opportunity Date for EPIDIOLEX
Generic Entry Date for EPIDIOLEX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for EPIDIOLEX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Hurd,Yasmin, Ph.D.Phase 2
Hans and Mavis Lopater FoundationPhase 2
Dana-Farber Cancer InstitutePhase 2

See all EPIDIOLEX clinical trials

US Patents and Regulatory Information for EPIDIOLEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gw Res Ltd EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gw Res Ltd EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gw Res Ltd EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gw Res Ltd EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gw Res Ltd EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gw Res Ltd EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gw Res Ltd EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for EPIDIOLEX

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Colorcon
Johnson and Johnson
Moodys
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.